Kornimate/medical-research-clean huggingface dataset:
evaluation montelukast in the treatment of status asthmaticus

Conditions: Status Asthmaticus

Summary: the purpose of this study is to evaluate the effectiveness of oral montelukast (singulair) given with other standard asthma medications and treatments in the treatment of children with status asthmaticus. status asthmaticus is an acute asthma attack that does not respond to standard intermittent treatments but requires a continuous medication to aid in breathing. while new medications have been used to better manage chronic asthma, acute asthma exacerbations continue to be a significant cause of hospitalization and even death in children. oral montelukast is a very safe medication that is used to manage chronic asthma in children, but it has not been studied for use in status asthmaticus. if oral montelukast, given with other standard therapies, can reduce the treatment length associated with severe, acute asthma exacerbations in children, it could potentially improve both the morbidity and burden of pediatric asthma.

while new medications have been used to better manage chronic asthma, acute exacerbations continue to be a significant cause of pediatric morbidity and mortality. montelukast holds an established role in the pediatric outpatient management of asthma and while two promising studies in adults have demonstrated its potential use as an adjunctive therapy for acute exacerbations, its similar use in pediatrics has yet to be established. this pilot study is designed as a prospective, double blinded, randomized, controlled, clinical trial comparing the use of oral montelukast plus standard of care vs. standard of care alone in children admitted for status asthmaticus to the pediatric intensive care unit (picu). the primary outcome the investigators are interested in is the time to reach a modified pediatric asthma score (pas) of \< 5, which, per the clinical protocol for the treatment of status asthmaticus, is the time when patients are able to come off continuous bronchodilator therapy. if oral montelukast, given with other standard therapies, can reduce the treatment, emotional, and financial burden (e.g., shortened intensive care stay) associated with severe, acute asthma exacerbations in children, it would provide a significant therapeutic advantage, potentially improving both the morbidity and burden of pediatric asthma.

Eligibility criteria:
inclusion criteria: * between ages 2-148 years * requiring picu admission for status asthmaticus * able to take oral medication * pediatric asthma score \> 8 on admission exclusion criteria: * intubated patients or other patients unable to take medications by mouth secondary to anatomic or pre-existing craniofacial issues * patients already on montelukast as their controller medication * patients with a known allergy to montelukast * any patient with phenylketonuria (pku) * any patient currently on treatment with rifampin, fluconazole, or phenobarbital medications

Keywords: montelukast singulair status asthmaticus
a study to evaluate the effect of food on the drug levels of bms-986196 in healthy adult participants

Conditions: Healthy Adult Volunteers

Summary: the purpose of this study is to assess the drug levels of bms-986196 and to evaluate the effect of food (fasted versus fed \[high-fat meal\]) on the drug levels after administration of bms-986196 tablet formulation at two dose levels in healthy adult participants.


Eligibility criteria:
inclusion criteria: * healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory assessments. * body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and body weight ≥ 50 kg. * participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten). exclusion criteria: * any significant acute or chronic medical illness in the assessment of the investigator. * current or recent (within 3 months of study intervention) gastrointestinal (gi) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure) * any major surgery, including gi surgery (for example, cholecystectomy and any other gi surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable). note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986196 healthy adult participants pharmacokinetics cross-over study
the icu delirium in clinical practice implementation evaluation study screening and treatment

Conditions: Delirium

Summary: objective: delirium is an important and frequently occurring complication in intensive care patients. however, screening and treatment of delirium is not in accordance with current national and international guidelines. the first objective of this prospective study is to describe the barriers and facilitators for guideline adherence. second, investigators will develop a tailored implementation strategy. finally, investigators will describe the effects of the tailored implementation on the adherence of the guideline in a pilot study. design: current practices, attitudes and deviations from a national (dutch) delirium guideline will be assessed in a prospective before-measurement. barriers and facilitators will be identified with surveys and focus group interviews. adherence to the guideline will be studied in a before-after study in 7 icus in the southwest of the netherlands. further, the effect of a multifaceted implementation strategy-guided implementation will be assessed with regard to important clinical outcomes, such as mortality and delirium incidence. population: professionals (physicians/intensivists, nurses' and psychiatrists) and icu patients. intervention: the delirium guideline of the netherlands society of intensive care (nvic) is implemented in this study. implementation strategies: barriers and facilitators will be determined in focus group interviews (n=7) with health care professionals resulting in a tailored guideline implementation strategy. in the development of the strategies specific attention will be paid to sustaining the guideline adherence. main outcome: 1. current practices; 2. barriers and facilitators for guideline adherence; 3. tailored implementation strategy; 4. percentage of adherence to the guideline (early screening, prevention and treatment of delirium); 5. effects of implementation on outcomes (economic, mortality, delirium incidence). data analysis / power: the main effects, guideline adherence, will be evaluated by comparing the before and after measurements. calculating from 90% power,2-sided alpha=0.01, 231 patients per periods will be sufficient to test the proposed adherence of 85%. economic evaluation: the economic analysis will be performed from a health care perspective. investigator will calculate and compare the direct medical costs of usual care (before) and care after implementation of the guideline. additionally, the cost of the tailored guideline implementation process will be calculated. the economic analysis will be a cost-minimalization analysis.


Eligibility criteria:
inclusion criteria: * screening delirium by all patients * measuring of guide line adherence for all professionals working on the icu * implementation guideline: all professionals exclusion criteria: * no

Keywords: intensive care unit delirium implementation guideline
korean rosuvastatin effectiveness study in nondiabetic metabolic syndrome

Conditions: Hypercholesterolemia

Summary: the primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of ldl-c in subjects with metabolic syndrome after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: * metabolic syndrome patient; presence of 3 or more of the following: * abdominal obesity (waist circumference): men \> 90cm(36 inch), women \> 80cm(32 inch) * triglycerides ≥ 150 mg/dl (1.70 mmol/l) * hdl-c: men \< 40 mg/dl (1.04 mmol/l), women \< 50 mg/dl (1.3 mmol/l) * bp ≥130/≥85 mmhg or subject receiving anti-hypertensive treatment * fasting blood glucose 110 mg dl (6.11 mmol/l) - 125 mg/dl (6.94 mmol.l) * elevated ldl-c concentrations reported within 4 weeks of visit 1 as follows; * ≥ 130 mg/dl (3.36 mmol/l) to \< 220 mg/dl (5.69 mmol/l) in statin naive subjects (subjects who have not taken any lipid-lowering therapy known to affect ldl-c in the 4 weeks prior to visit 1) * ≥ 100 mg/dl (2.59 mmol/l) to \< 160 mg/dl (4.14 mmol/l) in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1 * triglyceride levels \< 400 mg/dl (4.52 mmol/l) * women of childbearing potential should be using a medically acceptable form of chemical or mechanical contraception. exclusion criteria: * history of known diabetes mellitus * use of anti-hyperglycaemic medication. * history of serious or hypersensitivity reactions to hmg-coa reductase inhibitors, in particular history of myopathy. * no chd or chd risk equivalents and 0-1 risk factors and framingham 10-year risk is \<10%. * history of heterozygous or homozygous familial hypercholesterolaemia or known type iii hyperlipoproteinaemia (familial dysbetalipoproteinaemia). * active arterial disease such as unstable angina pectoris, myocardial infarction, transient ischaemic attack (tia), cerebrovascular accident (cva), coronary artery bypass surgery (cabg) or angioplasty within 2 months prior to entry in the dietary lead in period * uncontrolled hypothyroidism defined as thyroid stimulating hormone (tsh) \> 1.5 times the upper limit of normal (uln) at visit 2 or subjects whose thyroid replacement therapy was initiated within 3 months of entry into dietary lead-in phase. * current active liver disease (alanine aminotransferase \[alt\] \> 2 x uln) or severe hepatic impairment. * unexplained serum ck \>3 times uln (e.g. not due to recent trauma, intramuscular injections, heavy exercise, etc). * serum creatinine \> 176 umol/l (2.0 mg/dl) * history of alcohol, or drug, abuse or both.

Keywords: hypercholesterolemia with nondiabetic metabolic syndrome
high-protein high-fiber diet in patients with primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis. there are few studies on dietary management in primary biliary cirrhosis and most of them have focused on micronutrients specifically vitamin d intake to prevent osteoporosis, and lipid control to prevent hyperlipidemia, but few recommendations have been made regarding a complete dietary approach. fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease endogenous catabolism in cirrhotic patients. the purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the nutritional status of patients with primary biliary cirrhosis.


Eligibility criteria:
inclusion criteria: * controls diagnose of primary biliary cirrhosis: * biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation * presence of antimitochondrial antibodies (ama) * histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts. ambulatory patients * cases diagnose of primary biliary cirrhosis: * biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation * presence of antimitochondrial antibodies (ama) * histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts. diagnose of liver cirrhosis by two or more of the following criteria: * albumin \< 3.4 g/dl * inr ≥ 1.3 * total bilirubin ≥ 2 mg/dl * portal hypertension (esophageal varices, splenomegaly, ascites, etc.) * liver biopsy ambulatory patients exclusion criteria: * overlapping syndrome with predominant autoimmune hepatitis * hospitalized patients * acute or chronic renal failure * hepatocellular carcinoma * pregnancy * neuropsychiatric disorders (schizophrenia, bipolar disorder, dementia and attention-deficit hyperactivity disorder)
pilot survey of dengue fever in solomon islands

Conditions: Arbovirus Infections

Summary: since 2009, kaohsiung medical university hospital organized a medical team to provide the medical service for people in solomon islands thru taiwan health center at the local. in addition to malaria and pulmonary tuberculosis, the investigators also found dengue virus, japanese encephalitis virus, chikungunya virus infections and intestinal parasitic infections might be the existing but overlooked and neglected medical issues in solomon islands. these infections show similarity in clinical manifestations and usually difficulty in clinical diagnosis, instead these infections rely on the laboratory identification with good laboratory quality and facility.

in this study, the investigators plan to investigate the local people, either from the community or the hospitals, to identify the prevalence and incidence of dengue fever, including laboratory identification of related infections for differential diagnosis, including japanese encephalitis virus, chikungunya virus and intestinal parasitic infections. intestinal parasite survey has been the routine long-term service offered by the kaohsiung medical university hospital in solomon islands. at the same time, the subjects enrolled in this study will also be asked the common medical illness in solomon islands (i.e. malaria, pulmonary tuberculosis and metabolic syndrome etc.) in order to delineate the association of dengue fever and these acute and chronic illness.

Eligibility criteria:
inclusion criteria: * healthy volunteer * reported dengue virus infection volunteer * people who understand the purpose of the study and agree the to sign the informed consent exclusion criteria: * people who refuse to join the study

Keywords: dengue virus
using shared decision making to improve kidney transplantation rates

Conditions: End Stage Renal Disease; Kidney Failure

Summary: the goal of this clinical trial is to increase shared decision-making between dialysis providers and patients in order to increase patients' probability of transplantation and to reduce socioeconomic/racial disparities in access to kidney transplantation. participants will receive educational material over the course of 4-6 months about different aspects of the kidney transplant and waitlisting process.

kidney transplantation is the preferred treatment choice for patients with end stage kidney disease (eskd), yet only a small proportion of patients with incident eskd are counseled about their transplant options. often, a smaller minority of patients reach the transplant waitlist in a timely manner. increasing the likelihood of transplantation for patients with eskd can lead to longer survival, better quality of life, and reduced costs of care. the kidney transplant and waitlist process is a complex and multi-step process that occurs over an extended period of time. this process involves transitions of care between multiple providers and requires patients to be proactive in their medical evaluations. this study will deliver educational materials to dialysis care teams and provide quarterly, personalized informational letters to patients, with the aim of increasing shared decision-making between patients and providers by giving them the information needed to initiate conversations about kidney transplantation.

Eligibility criteria:
inclusion criteria: * on a waitlist or undergoing an evaluation at the columbia university/new york presbyterian hospital (cu/nyph) transplant center or at the cleveland clinic (cc) * receiving hemodialysis at one of the following dialysis clinics: * fresenius kidney care city dialysis * davita kidney care haven dialysis * davita melrose dialysis * davita highbridge dialysis * rogosin institute east side dialysis unit * rogosin institute west side dialysis unit exclusion criteria: * speaking a language other than english or spanish * younger than 18 years of age

Keywords: kidney transplant transplantation shared decision making
toripalimab plus stereotactic body radiotherapy for hcc with pvtt

Conditions: Hepatocellular Carcinoma

Summary: to explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.

programmed cell death protein-1 (pd-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. additionally, previous studies showed that stereotactic body radiotherapy (sbrt) was effective for hepatocellular carcinoma with portal vein tumor thrombus (pvtt). no study has evaluated the efficacy and safety of toripalimab plus sbrt for hepatocellular carcinoma with pvtt. thus, the investigators carried out this prospective study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to mrecist criteria * the normal liver volume in the non-target area was greater than 700ml * portal vein tumor thrumbus confirmed in two image techniques * eastern cooperative oncology group performance status of 0 to 2 * no cirrhosis or cirrhotic status of child-pugh class a only * with no previous radiotherapy and immunotherapy * not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy. * the following laboratory parameters: platelet count ≥ 75,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/ l serum albumin ≥ 30 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma toripalimab stereotactic body radiotherapy portal vein tumor thrombus
eye dryness evaluation in primary sjögren's syndrome

Conditions: Primary Sjögren Syndrome

Summary: the objective of this observational study is to develop new tools to assess primary sjögren's syndrome (pss) symptoms and to measure the severity of eye involvement in these patients.

all clinical trials evaluating the efficacy of immunomodulatory drugs in pss are negative. this could be due to a lack of sensitivity of the outcome measures used so far to define the response. in this study, investigator will evaluate the feasability, tolerability, and performance of new tools to assess disease evolution: * investigator will develop a webapp to measure the intensity of the symptoms at home on a daily basis (ecological assessment) * investigator will evaluate new ophthalmologic procedures, already used in other conditions but never in pss, which assess the severity of eye involvement in the disease * investigator will develop an automated method to score the severity of ocular surface lesions in the disease. patients with a diagnosis of pss will be included in the study, will undergo detailed ophtalmologic examination, and will then use a webapp, installed on their smartphone, to score their symptoms everyday during 3 months.

Eligibility criteria:
inclusion criteria: * diagnosis of pss according to acr/eular classification criteria exclusion criteria: * patient does not possess a smartphone with web connection * patient unable to sign an informed consent
evaluation of the hsv 1 & 2 assay in specimens from symptomatic subjects

Conditions: Herpes Simplex Infections

Summary: this clinical performance study is being conducted to evaluate the performance of the aptima herpes simplex viruses 1 \& 2 assay for detection of herpes simplex virus (hsv) type 1 (hsv-1) and hsv type 2 (hsv-2) in swab samples prospectively collected from suspected hsv lesions. specimens collected using swabs from viral transport medium (vtm)collection kits and aptima swab collection kits will be evaluated.


Eligibility criteria:
inclusion criteria: * the subject has at least 1 active lesion (lesion with exudates and cellular material; eg, vesicle, ulcer) that is suspected to be caused by hsv (as determined by the clinician) * the subject and/or legally authorized representative is willing and able to provide consent prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board-approved waiver for parental consent for minors) exclusion criteria: * the subject has only hsv lesions without exudates and cellular material * the subject used a topical or oral antiviral medication used to treat hsv within 21 days of enrollment * subject already participated in this study * subject has a history of illness that the principal investigator (pi) or designee considers could interfere with or affect the conduct, results, and/or completion of the study * subject has a history of illness that the pi or designee considers could create an unacceptable risk to the subject if enrolled in the study
shox2_ptger4 dna methlyation in lung cancer

Conditions: Lungcancer

Summary: data on shox2 and ptger4 dna methylation suggest possible use as a biomarker for early lung cancer diagnosis. in this study a control group consisting of copd patients with a ct-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included. shox2 and ptger4 will be analyzed via pcr.

data on shox2 and ptger4 dna methylation suggest possible use as a biomarker for early lung cancer diagnosis. in this study a control group consisting of copd patients with a ct-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included. a total of 150 patients will be enrolled in this study. shox2 and ptger4 will be analyzed via pcr of blood plasma samples.

Eligibility criteria:
inclusion criteria: suspicious finding for lung cancer on ct-scan exclusion criteria: * history significant for former malignant diseases